Chemical Regulation in the European Union:
Registration, Evaluation, and Authorization
of Chemicals
Linda-Jo Schierow
Specialist in Environmental Policy
February 2, 2010
Congressional Research Service
7-5700
www.crs.gov
RS22673
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repared for Members and Committees of Congress
Chemical Regulation in the European Union
Summary
On June 1, 2007, the European Union (EU) began to implement a new law governing chemicals
in EU commerce, Registration, Evaluation, Authorization, and Restriction of Chemicals
(REACH). It is intended to protect human health and the environment from hazardous chemicals
while at the same time protecting the competitiveness of European industry. REACH evolved
over eight years and reflects compromises reached among EU stakeholders. The final regulation
reduces and coordinates EU regulatory requirements for chemicals new to the EU market and
increases collection of such information for chemicals already in the EU market, thus potentially
removing disincentives to innovation that existed under the former law. It also shifts
responsibility for safety assessments from government to industry and encourages substitution of
less toxic for more toxic chemicals in various chemical applications. U.S. chemical industry
representatives believe that REACH is “impractical.” In contrast, some public-interest groups are
urging U.S. legislators to adopt a similar legislative approach.
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Chemical Regulation in the European Union
Contents
Background ................................................................................................................................ 1
Views.......................................................................................................................................... 2
Contacts
Author Contact Information ........................................................................................................ 3
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Chemical Regulation in the European Union
epending on one’s point of view, new chemicals legislation in the European Union (EU)
is likely to vastly improve environmental and public health protections and serve as a
D model for future U.S. law, or it might unnecessarily burden commercial enterprises with
regulations and interfere with international trade. The subject of such conjecture is a new EU law
for Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) in EU
commerce, which went into force June 1, 2007.
Background
On June 1, 2007, the EU began to implement a new approach to the management of chemicals in
EU commerce. The REACH directive simplifies and consolidates more than 40 former
regulations in an effort to balance two EU goals: to protect public health and the environment
from hazardous chemicals and to ensure the continuing competitiveness of European industry.
Although certain chemicals are exempt entirely, and requirements for the other chemicals will be
phased in over 11 years, the law generally will apply to nearly all chemicals in EU commerce,
including imported chemicals, chemical mixtures, and certain articles that release chemicals to
the environment.
The REACH legislation is based on a proposal developed by the EU General Directorates for
Enterprise and Environment, which was adopted by the European Commission in February 2001.
The draft law was revised several times in response to public comments and amendments adopted
by the European Parliament and Council of Ministers (which is comprised of the executive
officers of EU member states). The final regulation is binding on all member states.
REACH requires all chemical producers and importers of more than one metric ton (t) per year of
any chemical1 to register the product by submitting a technical dossier of information about the
properties of that chemical and its uses to a new agency created by the law, the European
Chemicals Agency (ECHA).2 The dossier also must contain information about how any risks
associated with use of that chemical should be managed. Downstream users of chemicals are
required to manage their risks in the manner indicated by producers. Information requirements for
the dossier increase as production volume increases beyond 10 t, 100 t, and 1,000 t. Since June 1,
2008, when the ECHA began to function, registration has been required for new chemicals before
they enter commerce. Companies had between one year and 18 months to pre-register existing
chemicals. Pre-registration ended November 30, 2008. The first registration deadline for existing
chemicals is in November 2010, and applies only to substances of “very high concern,” or
substances produced in volumes greater than 1,000 t annually or greater than 100 t annually if
they are very toxic to aquatic life.
Member states (that is, the nations of the EU) evaluate the dossiers based on guidelines provided
by the ECHA, and may require additional data, if such data are needed to assess health and
1 All polymers and some intermediate chemicals are exempted from at least some provisions. Chemicals sold for
specific regulated purposes (for example, to control agricultural pests or to treat medical conditions) also are not
affected by the new law.
2 A metric ton is 1,000 kilograms, or about 2,200 pounds. The current EU requirement for registration applies to
chemicals produced or imported in amounts equal to or greater than 10 kilograms, but only if they have not been
produced or imported into the EU previously—so-called “new” chemicals.
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environmental effects of potential chemical exposure. Member states also may determine that
action should be taken to authorize or restrict particular chemical uses.
Producers of chemicals of “very high concern” may be required to apply for authorization of each
particular use, demonstrate that the risks can be adequately controlled (for example, through
labeling or worker training), and justify such uses by submitting additional information to
authorities. Companies will not be allowed to manufacture, import, or use a chemical after a
specified date unless they have obtained an authorization for a use. In addition, producers will be
required to submit an analysis of possible substitutes, a “substitution plan” if substitutes are
available, or a research and development plan if no suitable substitute exists.
As of February 2, 2010, ECHA had recommended seven substances for listing as substances of
very high concern and identified roughly 32 chemicals or chemical groups as candidate
substances of very high concern,3 but many more were being evaluated for this designation,
including approximately 1,350 chemicals known or likely to be carcinogens, mutagens, or
chemicals toxic to reproductive systems; persistent, bioaccumulative, and toxic chemicals (PBTs);
or very persistent and very bioaccumulative chemicals (vPvBs). According to the law, no use of
PBTs or vPvBs is to be authorized unless there is no suitable alternative, and the socio-economic
benefits of the use outweigh the risks. If a chemical use presents unacceptable risks, that chemical
use may be restricted. The EU Commission will decide within six years whether endocrine
disruptors also are of very high concern and should be subject to similar requirements.4 High-
production-volume chemicals routinely will be subject to the authorization process. The
authorization and restriction processes also may be applied to chemicals produced or imported in
volumes less than 1 t.
Views
The U.S. Government was actively engaged throughout the development of REACH. The Bush
Administration expressed concerns about its trade implications for U.S.-produced chemicals.5
Specific concerns included increased costs of and time lines for testing chemicals exported to the
EU; placement of responsibility on businesses (as opposed to governments or consumers) to
generate data, assess risks, and demonstrate the safety of chemicals; possible inconsistency with
international rules for trade adopted by the World Trade Organization (WTO); and the effect of
the legislation on efforts to improve the coherence of chemical regulatory approaches among
countries in the Organization for Economic Cooperation and Development (OECD).
U.S. chemical industry representatives believe that REACH is “impractical.” Industry has
expressed objections to the proposed list of “high concern” chemicals, some of which are
essential building blocks for the manufacture of other chemicals. The EU chemical industry is
3 European Chemicals Agency, “Recommendation of the European Chemicals Agency (ECHA) of 1 June 2009 for the
inclusion of substances in Annex XIV (the list of substances subject to authorisation) of Regulation (EC) No
1907/2006,” at http://echa.europa.eu/doc/authorisation/annex_xiv_rec/annex_xiv_subst_inclusion.pdf, and “Candidate
list of substances of very high concern for authorisation,” at http://echa.europa.eu/chem_data/
candidate_list_table_en.asp.
4 Endocrine disruptors are chemicals that interfere with the normal functioning of glands or the hormones they produce.
For more on endocrine disruptors in the environment, see CRS Report R40177, Environmental Exposure to Endocrine
Disruptors: What Are the Human Health Risks?, by Linda-Jo Schierow and Eugene H. Buck.
5 Prescott, Jennifer Yoder, “U.S. Government Responds to the E.U. Chemicals Policy,” Chemistry Business, June 2002.
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concerned about the cost of compliance, and what it might mean to innovation and international
competitiveness. Some national governments of the EU also are concerned about the impact of
REACH on their economies and employment, especially if REACH leads to companies
relocating outside the EU. The EU has estimated that about 12% of chemicals in commerce will
be withdrawn by chemical producers, because continued production under REACH will be costly
and distribution not sufficiently profitable to recoup costs. In cases where no substitute is
available, loss of a production source might leave some end users without the chemicals they
need.
Many environmental, health, and U.S. and EU labor organizations strongly supported the original
proposal for REACH, but some are less enthusiastic about the final regulation, which retains its
basic purpose and shape but exempts some chemicals from requirements. Nevertheless, these
groups agree that REACH addresses what they see as flaws in U.S. and EU laws covering
chemicals.6 (For more information about U.S. chemical law, see CRS Report RL31905, The Toxic
Substances Control Act (TSCA): A Summary of the Act and Its Major Requirements, by Linda-Jo
Schierow.) For example, REACH reduces and coordinates EU regulatory requirements for
providing health and safety information about chemicals new to the EU market (as well as the
number of new chemicals subject to such requirements), while at the same time increasing
collection of such information for chemicals already in the EU market, thus potentially removing
disincentives to innovation and substitution of less toxic for more toxic chemicals in various
chemical applications. In addition, to address concerns about the slow pace of chemical risk
assessment and management by the EU government, REACH shifts responsibility for assessing
and managing the safety of chemicals away from the government and onto chemical
manufacturers, importers, and users. Some public interest groups are urging U.S. legislators to
adopt a similar legislative approach.7 For more discussion of the perceived flaws of U.S. law, see
CRS Report RL34118, The Toxic Substances Control Act (TSCA): Implementation and New
Challenges, by Linda-Jo Schierow.
Author Contact Information
Linda-Jo Schierow
Specialist in Environmental Policy
lschierow@crs.loc.gov, 7-7279
6 See, for example, the presentation by Daryl Ditz of the Center for International Environmental Law at
http://www.chemicalstrategies.org/pdf/workshop_events/DDitz_Emerging%20Int%27l%20Issues.pdf.
7 Ibid.
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